Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 085551
Company: BAXTER HLTHCARE

Products on ANDA 085551

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HYDROXYZINE	HYDROXYZINE HYDROCHLORIDE	50MG/ML	INJECTABLE;INJECTION	Discontinued	None	No	No
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	25MG/ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 085551

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/24/1979	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/06/2000	SUPPL-36	Manufacturing (CMC)-Control		Label is not available on this site.
07/18/1997	SUPPL-33	Manufacturing (CMC)		Label is not available on this site.
07/18/1997	SUPPL-32	Manufacturing (CMC)		Label is not available on this site.
08/19/1993	SUPPL-31	Manufacturing (CMC)		Label is not available on this site.
08/06/1991	SUPPL-30	Labeling		Label is not available on this site.
05/21/1991	SUPPL-29	Labeling		Label is not available on this site.
04/24/1990	SUPPL-28	Manufacturing (CMC)		Label is not available on this site.
10/12/1989	SUPPL-27	Labeling		Label is not available on this site.
05/01/1989	SUPPL-26	Labeling		Label is not available on this site.
12/09/1988	SUPPL-24	Labeling		Label is not available on this site.
10/17/1988	SUPPL-22	Labeling		Label is not available on this site.
10/22/1985	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
03/27/1985	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
01/19/1984	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
09/30/1982	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.